Reconstitution device, system, and method to administer a drug in a moderate bolus

ABSTRACT

A reconstitution device includes: a piercing member having a first end and a second end, the first end of the piercing member configured to engage an administration port; a delivery member having a first end and a second end, the first end of the delivery member configured to engage a delivery site; a collar configured to engage a vial; and a cap extending from the collar and holding the piercing member and the delivery member such that the second end of the piercing member and the second end of the delivery member are disposed within the cylindrical collar.

BACKGROUND

Medical therapy often requires the intravenous administration of, forexample, fluids to correct electrolyte imbalance, medicated solutions todeliver medication, and/or nutrients to provide nutrition to patientsunable to receive oral or enteral nutrition. Intravenous (“IV”) fluidsare generally available in aseptic single- or multi-chamber flexiblecontainers that include an administration port and a medication port. AnIV administration set is typically inserted into a flexible container(e.g., an IV bag) via the administration port to allow administration ofthe fluids from the flexible container to the patient. Likewise,medications and/or nutrients can be injected, into the flexiblecontainer, via the medication port.

Certain active agents, such as medications and nutrients, which areunstable in liquid form, are stored in dry form. For example, activeagents may be unstable at the pH of the IV fluid, susceptible to light,etc., thus requiring dry form storage. Typically, dry form active agentsmay be stored in glass vials, sealed with rubber stoppers, or othercontainers such as plastic containers, ampoules, or small bags that maybe closed with standard screw caps. Prior to being administered to apatient, these dry form active agents are reconstituted. Reconstitutiontypically includes removing a protective cover to expose the rubberstopper, wiping the stopper with an antiseptic wipe, adding diluent tothe vial by inserting a needle of a syringe through the rubber stopperand depositing the contents of the syringe, such as diluent, into thevial, and shaking the vial to fully dissolve or suspend the activeagents. Subsequently, the resulting reconstituted solution or suspensionis withdrawn from the vial by inserting a needle of a syringe throughthe rubber stopper, aspirating the solution or suspension into thesyringe, and injecting the contents of the syringe into the flexiblecontainer via the medication port. Some medications and nutrients,however, begin to degrade as soon as they are mixed into the flexiblecontainer. Ascorbic acid, vitamin B 1, and vitamin C, for example,degrade in total parenteral nutrition mixtures, while vitamins A and Edegrade in parenteral nutrition mixtures upon exposure to light.

An improved system and method for using a reconstitution device toadminister medications, especially quickly degrading medications, isneeded accordingly.

SUMMARY

To improve the administration of medications, especially those thatdegrade quickly, a new patient medication delivery paradigm must beimplemented. Implementing a new and alternate way of medicationadministration requires, for example, a new and alternate reconstitutiondevice, system, and method. More specifically, a reconstitution devicecan be configured to establish a fluid pathway between a source (e.g.,an IV bag) and a location (e.g., a patient). Along this fluid pathway, adrug (e.g., a powdered drug, a lyophilized drug, or a liquid drug) maybe introduced, via reconstitution device connectivity with a drugcontainer, such as a drug vial.

In light of the disclosure herein, and without limiting the scope of theinvention in any way, in a first aspect of the present disclosure, whichmay be combined with any other aspect listed herein unless specifiedotherwise, a reconstitution device includes a piercing member, adelivery member, a collar, and a cap. The piercing member has a firstend and a second end. The first end of the piercing member is configuredto engage an administration port. The delivery member has a first endand a second end. The first end of the delivery member is configured toengage a delivery site. The collar is configured to engage a vial. Thecap extends from the collar and holds the piercing member and thedelivery member, such that the second end of the piercing member and thesecond end of the delivery member are disposed within the collar.

In a second aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the cap isformed integrally with the collar.

In a third aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the collar iscylindrical and is configured to concentrically engage the vial.

In a fourth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the collarengages with the vial, such that the piercing member is in fluidcommunication with the vial and the delivery member is in fluidcommunication with the vial.

In a fifth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, theadministration port is an IV bag port, and the first end of the piercingmember is configured to pierce the IV bag port.

In a sixth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the deliverysite is an IV line, connectable to a patient, and the first end of thedelivery member is configured to connect to the IV line.

In an seventh aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, whenplaced in an operating position, each of the piercing member and thedelivery member are oriented vertically.

In a eighth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the first endof the piercing member is formed integrally with the administrationport.

In a ninth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, theadministration port is connected to an IV solution container.

In an tenth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, at least oneof the first end of the piercing member, the second end of the piercingmember, and the second end of the delivery member includes a syringeneedle.

In an eleventh aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, areconstitution system includes a drug vial, a fluid container, and areconstitution device. The reconstitution device includes a piercingmember, a delivery member, a collar, and a cap. The piercing member hasa first end and a second end. The first end of the piercing member isconfigured to engage the fluid container. The delivery member has afirst end and a second end. The first end of the delivery member isconfigured to engage a delivery site. The cap extends from the collarand holds the piercing member and the delivery member, such that thesecond end of the piercing member and the second end of the deliverymember are disposed within the collar.

In a twelfth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thecollar engages the vial, such that the piercing member is in fluidcommunication with the vial and the delivery member is in fluidcommunication with the vial.

In a thirteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thefluid container holds a fluid, such that the fluid may travel from thefluid container into the first end of the piercing member, through thepiercing member, from the second end of the piercing member into thevial, from the vial into the second end of the delivery member, throughthe delivery member, and from the first end of the delivery member tothe delivery site.

In a fourteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, the vialcontains an active agent.

In a fifteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, theactive agent is a pharmaceutical agent or a nutritional supplement.

In a sixteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thefluid container is an IV bag and the delivery site is an IV lineconnectable to a patient.

In a seventeenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, aninfusion pump is in operable communication with the IV line.

In a eighteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thefluid container is formed integrally with the reconstitution device.

In a nineteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, a methodof using a reconstitution system includes enabling a piercing member anda delivery member to be placed in simultaneous communication with aninside of a vial. The method further includes enabling fluid from acontainer to be introduced, via the piercing member, into the vial tomix with an agent located within the vial to form a mixed drug. Themethod further includes enabling the mixed drug to be delivered from thevial together with fluid from the IV bag, via the delivery member.

In a twentieth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, enablingthe mixed drug to be delivered from the vial, via the delivery member,includes enabling a distal end of the delivery member to be connected toa tube that is connectable to a patient.

In light of the disclosure and aspects set forth herein, it isaccordingly an advantage of the present disclosure to provide areconstitution system ensuring that administration is performed as amoderate bolus by delivering the reconstituted drug directly to the IVadministration set.

It is another advantage of the present disclosure to provide areconstitution system reducing drug degradation by reconstituting thedrug and immediately delivering it to the IV administration set.

It is a further advantage of the present disclosure to provide areconstitution system ensuring that it is a ready-to-use application bybeing configured to accept vials directly.

It is yet another advantage of the present disclosure to provide areconstitution system avoiding the tedious preparation steps involvedwith typical dried drug reconstitution by accepting vials directly.

It is yet a further advantage of the present disclosure to provide areconstitution system ensuring that drug prescriptions and deliveriesare not inadvertently missed by medical professionals by pre-pluggingthe vial.

It is still another advantage of the present disclosure to provide areconstitution system ensuring passive reconstitution by connecting thedrug vial in series with a delivery site, such that, in one embodiment,no additional action is required for reconstitution to take place.

It is still a further advantage of the present disclosure to provide areconstitution system ensuring that microbiological contamination riskis minimized by accepting pre-plugged vials in a sterile manner.

Additional features and advantages of the disclosed devices, systems,and methods are described in, and will be apparent from, the followingDetailed Description and the Figures. The features and advantagesdescribed herein are not all-inclusive and, in particular, manyadditional features and advantages will be apparent to one of ordinaryskill in the art in view of the figures and description. Also, anyparticular embodiment does not necessarily have to have all of theadvantages listed herein. Moreover, it should be noted that the languageused in the specification has been principally selected for readabilityand instructional purposes, and not to limit the scope of the inventivesubject matter.

BRIEF DESCRIPTION OF THE FIGURES

Understanding that figures depict only typical embodiments of theinvention and are not to be considered to be limiting the scope of thepresent disclosure, the present disclosure is described and explainedwith additional specificity and detail through the use of theaccompanying figures. The figures are listed below.

FIG. 1 is a perspective view of one embodiment of a reconstitutiondevice, according to an example embodiment of the present disclosure.

FIG. 2 is an elevation sectioned view of the reconstitution device ofFIG. 1, further illustrating its fluid flow paths, according to anexample embodiment of the present disclosure.

FIG. 3 is a perspective view of one alternative embodiment of areconstitution device of the present disclosure, which includes anintegrated fluid container.

FIG. 4 is a plot of the absorbance of a reconstituted solution as afunction of administered volume, as performed by a reconstitution deviceof the present disclosure.

FIG. 5 is a schematic view of one embodiment of a system employing anyof the reconstitution devices described herein.

FIG. 6 is an elevation sectioned view of an alternate embodiment of thereconstitution device, illustrating an alternate configuration of flowpaths, according to an example embodiment of the present disclosure.

DETAILED DESCRIPTION

Certain embodiments described herein relate generally to the field of IVadministration of an active agent. More particularly, some embodimentsdescribed herein relate to reconstitution of an active agent in a vial,followed by IV administration of the active agent as a moderate bolususing an IV administration set directly connected to the vial.

As discussed herein, adding a dried drug to an IV bag typically includesseveral tedious steps. For example, a medical professional may berequired to remove a protective cover of a vial, wipe a stopper of thevial, add diluent to the vial, and shake the vial. The drug then has tobe withdrawn from the vial and injected into, for example, an IV line,an IV bag, etc. Additionally, as discussed above, once a drug isreconstituted, the drug begins to degrade immediately; thus, timing isall the more critical.

Typical commercially available vial reconstitution systems (e.g., theBaxter Vial-Mate™ system) are configured such that the drug contained inthe vial is added into the IV bag directly, via a port. In such systems,the drug from the vial is mixed with the entire IV bag prior to beingadministered to the patient. For example, the drug is delivered into theIV bag, via a medication port, mixes within the IV bag, and is thenadministered to the patient via an administration port (e.g., by an IVset connected to the IV bag at the administration port). In thisdelivery paradigm, the drug is not fully delivered until the entirecontents of the IV bag have been delivered. In other words, there is nomoderate bolus effect with respect to drug delivery. Moreover, thelonger the drug sits in the IV bag in a reconstituted state, whilewaiting to be delivered, the more likely it becomes that the drug willdegrade.

By comparison, the reconstitution system disclosed herein is configuredso that the vial containing the drug is connected directly with thedelivery site. The connection allows the reconstituted drug to traveldirectly to the delivery site, such as an IV set. Direct drug deliveryavoids the requirement of having to mix the drug in the IV bag. In thismanner, a reconstituted active agent may flow directly into the IVadministration set, delivering the active agent as a bolus during theinitial period of the IV therapy. Delivering the drug as a bolus reducesthe likelihood that the drug will degrade prior to delivery.

Referring now to the drawings and in particular to FIG. 1, oneembodiment of the reconstitution device of the present disclosure isillustrated by reconstitution device 10. Reconstitution device 10 may beconstructed of any suitable plastic or rubber material, such as PVC, nonDEHP PVC, Krayton polypropylene mixture, or other similar materials.

Reconstitution device 10 includes a cylindrical collar 20. In alternateembodiments, the collar 20 may be other cross sections (e.g., hexagonal,square, triangular, etc.). Cylindrical collar 20 is configured to engagea vial 25 (e.g., via concentric engagement). In the illustratedembodiment, the top of the vial 25 is received within cylindrical collar20, such that the cylindrical collar 20 is disposed around the outsideof the top of vial 25. Vial 25 typically contains an active agent suchas a pharmaceutical agent or a nutritional supplement. The active agentmay be present as a dried powder, such as a powder obtained bylyophilization. Alternatively, the active agent is present in an aqueoussolution or suspension, or more typical liquid form. As discussedherein, reconstitution device 10 is particularly useful for connectingto an IV line to deliver a moderate bolus to a patient.

Reconstitution device 10 also includes a hollow, fluid carrying piercingmember 30 connected to a cap 22 extending from collar 20. Cap 22 may beformed integrally with or be attached to collar 20. Piercing member 30as illustrated has a first end 32 and a second end 34. The first end 32of the piercing member 30 is configured to engage an administration portof an IV bag, so that vial 25 may be placed in fluid communication withthe IV bag. For example, the first end 32 of the piercing member 30 maybe configured to pierce the administration port (e.g., an IV bag port).The administration port may be connected to an IV solution container. Inan embodiment, the first end 32 of the piercing member 30 is formedintegrally with the administration port of the IV bag. For example, inan embodiment, the IV bag (e.g., the administration port and the IVsolution container) may be permanently fixed to the reconstitutiondevice 10, such that the reconstitution device 10 is manufactured andconfigured with the IV bag. Alternatively, for example, thereconstitution device 10 may be configured to engage with theadministration port of any typical IV bag. Piercing member 30 may bemade of metal (e.g., stainless steel), medical grade plastic, or anyother suitable material.

Reconstitution device 10 also includes a hollow, fluid carrying deliverymember 40, which extends from cap 22 connected to collar 20. Deliverymember 40 may be formed with (same material as) or be attached to cap22. Delivery member 40 as illustrated has a first end 42 and a secondend 44. The first end 42 of the delivery member 40 is configured toengage a delivery site. For example, the delivery site is an IV line,connectable to a patient. In an embodiment, delivery member 40 isconfigured for connecting the vial 25 to a delivery port of an IV line(e.g., at the first end 42 of the delivery member 40). In an embodiment,the first end 42 of the delivery member 40 includes a luer connector.Each of the first end 32 of the piercing member 30, the second end 34 ofthe piercing member 30 and the second end 44 of the delivery member 40may be or may include a syringe needle.

In the illustrated embodiment, each of the second end 34 of piercingmember 30 and second end 44 of the delivery member 40 are disposedwithin cylindrical collar 20 of reconstitution device 10. As notedpreviously, cylindrical collar 20 is configured to concentrically engagethe vial 25 (e.g., the top of the vial 25). In an embodiment, byconcentrically engaging cylindrical collar 20 with the vial 25, each ofthe second end 34 of piercing member 30 and the second end 44 ofdelivery member 40 extend into the vial 25 when device 10 is mated tothe vial. For example, the piercing member 30 is in fluid communicationwith the vial 25. Likewise, for example, the delivery member 40 is influid communication with the vial 25. In an embodiment, the second end34 of piercing member 30 and the second end 44 of delivery member 40extend through a rubber stopper on the top of the vial 25, such thatboth the second end 34 of the piercing member 30 and the second end 44of the delivery member 40 are in sealed fluid communication with theinside of vial 25.

FIG. 2 illustrates an expanded view of reconstitution device 10,highlighting its fluid flow pathways. For example, piercing member 30provides a first fluid pathway 36 extending between its first end 32 andits second end 34. Likewise, delivery member 40 provides a second fluidpathway 46 extending between its first end 42 and its second end 44.First fluid pathway 36 at the second end 34 of the piercing member 30and second fluid pathway 46 at the second end 44 of the delivery member40 are accordingly disposed within the vial 25 (not pictured) whendevice 10 is mated to the vial 25 as described above.

A complete fluid pathway is provided accordingly: fluid may flow fromthe first end 32 of piercing member 30, through the piercing member 30,from the second end 34 of piercing member 30 into the vial 25, from thevial 25 into the second end 44 of delivery member 40, through thedelivery member 40, and from the first end 42 of the delivery member 40to and/or into a delivery site, e.g., an IV line, connected to apatient.

First end 32 of piercing member 30 is sharpened to pierce and engage anadministration port, such as an IV bag port. First end 42 of thedelivery member 40 in the illustrated embodiment is provided with aconnector, e.g., a luer connector, to fluidly sealingly engage adelivery site, such as a mating luer connector of an IV line, which isin turn connected to a patient. Other types of connections, besides luerconnections, may be used, such as hose barbs or a compression fitting toconnect the first end 42 of delivery member 40 to the delivery site,e.g., an IV line tube.

Thus, in an example, fluid, such as saline or glucose from an IV bag,may travel into the first end 32 of the piercing member 30 andsubsequently into vial 25. The fluid mixes with the dry, e.g.,granulated, drug in vial 25 to form a drug solution. The drug solutionmay then flow from vial 25, through delivery member 40, out the firstend 42 of the delivery member 40 into a delivery site, such as an IVline.

Reconstitution device 10, in an embodiment, provides for verticalloading of the vial 25 into the cylindrical collar 20, wherein each ofvial 25, piercing member 30 and at least a portion of delivery member 40are oriented vertically. For example, when reconstitution device 10 isplaced in an operating position, each of the piercing member 30 and thedelivery member 40 are oriented vertically. In an embodiment,cylindrical collar 20 is oriented vertically such that, responsive toconcentric engagement with the vial 25, the vial 25 is held vertically.By ensuring that the vial 25 is engaged with the reconstitution device10 vertically (e.g., in a top-up configuration), reconstituted materialwill not inadvertently drip out of the vial 25. By comparison, if thevial 25 were oriented in a different manner (e.g., in a top-downconfiguration, sideways configuration, etc.), gravity may cause liquidwithin the vial 25 to leak out of the vial 25. The vertical orientationof the vial 25, in top-up orientation, minimizes leakage.

Referring now to FIG. 3, an alternative reconstitution device 60 of thepresent disclosure is illustrated. Reconstitution device 60 in theillustrated embodiment integrates fluid container 70, which may be arigid fluid container or a flexible fluid container. In one embodiment,fluid container 70 is an IV bag. Fluid container 70 may, for example, beprovided pre-loaded with a saline or glucose solution. The rigidportions of reconstitution device 60 may be made of any of the materialslisted above for device 10. Fluid container 70, if flexible, may be madeof any suitable material known to those of skill in the art.

Reconstitution device 60, like device 10, includes cylindrical collar20, which is configured to concentrically engage the top of vial 25, anda cap 22 holding piercing member 30 and delivery member 40. Piercingmember 30 includes the second end 34 as before and the first end 32formed with or connected to the administration port of fluid container70. Thus reconstitution device 60, in one embodiment, is provided as anintegrated unit with cylindrical collar 20, cap 22, piercing member 30,delivery member 40 and fluid container 70.

Delivery member 40 of reconstitution device 60 has the first end 42 andthe second end 44 as described above. First end 42 of the deliverymember 40 is configured to engage the delivery site as described above.Second end 34 of the piercing member 30 and second end 44 of deliverymember 40 are located, again, within cylindrical collar 20 of thereconstitution device 60 and extend into vial 25, as described above forsystem 10 (e.g., the top of the vial 25). In the illustrated embodiment,piercing member 30 is in fluid communication with both fluid container70 and the vial 25. Likewise, in the illustrated embodiment, thedelivery member 40 is in fluid communication with both the vial 25 andthe delivery site (e.g., an IV tube).

In an embodiment, fluid container 70 holds a fluid, such as saline orglucose, which travels from fluid container 70, into the first end 32 ofpiercing member 30, through the piercing member 30, from the second end34 of piercing member 30, into the vial 25 to mix with a dry, e.g., agranulated, powdered agent, to form a drug solution, wherein the drugsolution travels from vial 25 into the second end 44 of the deliverymember 40, through the delivery member 40, and from the first end 42 ofdelivery member 40 into the delivery site, e.g., an IV fluid lineconnected to a patient.

FIG. 4 illustrates an example of the absorbance of a reconstitutedsolution as a function of administered volume, when performed by areconstitution device according to an example embodiment of the presentdisclosure. This example provides an illustration of the performancecapability of an embodiment, and is not intended to limit the foregoingdisclosure in any respect.

More particularly, the chart depicted in FIG. 4 includes the absorbanceof a reconstituted solution of a multivitamin composition comprising fatsoluble and water soluble vitamins for infusion, as a function ofadministered volume using either reconstitution device 10 orreconstitution system 60 as depicted respectively in FIGS. 1 and 3described above. For example, the multivitamin composition, in alyophilized or sterile powder, may contain the following vitamins:

Retinol palmitate corresponding to Retinol (Vitamin A) 3500 IUCholecalciferol (Vitamin D₃) 200 IU DL α-tocopherol 10.2 mgcorresponding to α-tocopherol (Vitamin E) 11.2 IU Ascorbic Acid (VitaminC) 125 mg Nicotinamide (Vitamin B₃) 46 mg Dexpanthenol 16.15 mgcorresponding to pantothenic acid (Vitamin B₅) 17.25 mg Pyridoxinehydrochloride 5.5 mg corresponding to pyridoxine (Vitamin B₆) 4.53 mgRiboflavin sodium phosphate 5.67 mg corresponding to riboflavin (VitaminB₂) 4.14 mg Cocarboxylase tetrahydrate 5.8 mg corresponding to thiamine(Vitamin B₁) 3.51 mg Folic Acid 414 mcg D-Biotin 60 mcg Cyanocobalamin(Vitamin B₁₂) 5.5 mcg Other Ingredients Glycine 250 mg Glycocholic acid140 mg Soybean lecithin 112.5 mg

The chart depicted in FIG. 4 illustrates absorbance from a bolusadministration of the multivitamin solution as a function ofadministered volume using a 30% glucose solution bag (e.g., 500 mLformat size) obtained from an IV bag (e.g., fluid container 70). Thereconstituted solution was dyed, in yellow color, so that absorbance ofthe reconstituted solution could be measured during administration of200 mL of nutrition fluid. In this example, absorbance was measured atan optical wavelength of 446 nm.

The chart depicts absorbance peaking near the beginning of theadministration and subsequently decreasing, in an exponential fashion,as nutrition fluid is administered. The administration was stopped afteryellow color was no longer observed in the reconstituted solution vial.The chart illustrates two improvements provided by the reconstitutiondevice 10 (or reconstitution system 60). First, the chart illustratesthat that absorbance is highest at the initial stages of fluid delivery;absorbance decreases exponentially. This suggests that a significantportion of a reconstituted solution is delivered at the beginning of theadministration process. In other words, the reconstituted solution isdelivered as a moderate bolus. Moreover, by delivering the drug at thebeginning of administration, harmful effects associated with drugdegradation are reduced. Second, the chart illustrates that most of thereconstituted solution is delivered within the first several hundredmilliliters of fluid. For example, by 200 mL, almost no absorbance wasmeasurable. This suggests that the administration process disclosedherein is more efficient, requiring less fluid (e.g., saline, glucose,etc.) to deliver the drug effectively.

The above described reconstitution device, system, and method may beused, for example, during parenteral nutrition therapy. In this case,reconstitution may be used to enhance the administration of amultivitamin product that would otherwise be added to a total parenteralnutrition (“TPN”) bag through the medication port. Examples for knownparenteral nutrition products, which could be used with the presentdevice, system, and method, include Olimel, Oliclinomel, Clinomel,Clinimix, Numeta, ClinOleic, SmofKabiven, Kabiven, PeriKabiven,StructoKabiven, Aminomix, Nutriflex, Nutriflex Lipid, Pediaven etc. Invarious examples, the reconstitution device may be permanently connectedto a TPN bag, or may be added to the TPN bag prior to use. Likewise,either a multi-chamber bag or a single-chamber bag may be used with thepresent device, system, and method.

FIG. 5 illustrates one embodiment of a system 100 employing eitherreconstitution device 10 or reconstitution device 60 described above,configured to engage with drug vial 25. System 100 includes an IV bag110, hanging from a stand 120. The IV bag 110 may include a fluid, suchas saline, glucose, etc., for delivery to a patient 130. As illustrated,the IV bag 110 is positioned on the stand 120 to ensure that the IV bag110 is vertically above the patient 130. This may ensure, for example,that fluid in the IV bag 110 may flow to the patient 130 via a gravityflow.

System 100 includes reconstitution device 10. Reconstitution device 10engages with the IV bag 110 as previously described (e.g., via piercingmember 30). In an embodiment, the IV bag 110 is formed integrally withthe reconstitution device 10. System 100 also includes delivery tube140. In an example embodiment, delivery tube 140 is an IV tube. Deliverytube 140 engages with the reconstitution device 10 as previouslydescribed (e.g., via the first end 42 of delivery member 40). Deliverytube 140 also engages with a patient 130 at an IV location 150. Forexample, delivery tube 140 may include an intra-venous needle insertedinto the patient 130 at the IV location 150.

Delivery tube 140 is configured to convey the fluid in the IV bag 110from the reconstitution device 10 to the patient 130 at the IV location150. While flow conveyance may be facilitated by gravity, as describedabove with respect to the IV bag 110 positioning on the stand 120,additional or alternative modes of fluid conveyance may be implemented.For example, system 100 may further include an infusion pump 160, whichmay for example be a Sigma™ Large Volume Pump (“LVP”) provided by theassignee of the present disclosure. Infusion pump 160 may control fluidconveyance along delivery tube 140 (e.g., from the reconstitution device10 to the patient 130 at the IV location 150).

In an embodiment, a method of using the reconstitution system 100includes enabling the piercing member 30 and the delivery member 40 ofthe reconstitution device 10 to be placed in simultaneous communicationwith an inside of the vial 25. The method further includes enablingfluid from the IV bag 110 to be introduced, via the piercing member 30,into the vial 25 to mix with an agent located within the vial 25 to forma mixed drug. The method further includes enabling the mixed drug to bedelivered from the vial 25 together with fluid from the IV bag 110, viathe delivery member 40. In a related embodiment, enabling the mixed drugto be delivered from the vial 25, via the delivery member 40, includesenabling a distal end of the delivery member 40 to be connected to thedelivery tube 140 that is connectable to the patient 130.

For example, with reference to FIGS. 1 and 5, the fluid in the IV bag110 may travel into the first end 32 of the piercing member 30, andsubsequently travel into the vial 25. The fluid mixes with the drieddrug to form a reconstituted drug solution. The reconstituted drugsolution may then flow from the vial 25, through delivery member 40 andout the first end 42 of the delivery member 40, into delivery tube 140.The reconstituted drug solution may then flow to IV location 150, andsubsequently be administered to the patient 130.

The fluid conveyance process described above may, in certainembodiments, include additional steps. For example, the reconstitutiondevice 10 may initially engage the drug vial 25 at the cylindricalcollar 20; however, prior to this engagement, the delivery tube 140 maybe clamped (e.g., via a typical medical line clamp). The medicalprofessional may do this to initially ensure that any in-line air (e.g.,in delivery tube 140, in reconstitution device 10, etc.) is removed fromthe system 100. More particularly, once the reconstitution device 10 isaffixed to both the IV bag 110 and the delivery tube 140, any in-lineair may flow upwards to the IV bag. Upward air flow may be facilitatedby the IV bag 110 being positioned on the stand 120 so that it isvertically above the reconstitution device 10 and the patient 130. Themedical professional may further ensure that no in-line air remainsthrough additional techniques (e.g., tapping the reconstitution device10). Once all in-line air has been removed, the delivery tube 140 isunclamped and the fluid conveyance process described above occurs.

FIG. 6 illustrates an expanded view of an alternate embodiment of thereconstitution device 210, highlighting its alternate configuration offluid flow pathways. In this alternate configuration, there are threefluid flow pathways: a first fluid pathway 236, a second fluid pathway246, and a third fluid pathway 248.

More particularly, for example, piercing member 230 provides the firstfluid pathway 236 extending between its first end 232 and its second end234. Likewise, delivery member 240 provides the second fluid pathway 246extending between its first end 242 and its second end 244.Reconstitution device 210 also includes the third fluid pathway 248extending between the first end 232 of the piercing member 230 and thefirst end 242 of the delivery member 242. In this example, each of thefirst fluid pathway 236 and the third fluid pathway 248 share a same end(e.g., first end 232). Likewise, in this example, each of the secondfluid pathway 246 and the third fluid pathway 248 share a same end(e.g., first end 242). First fluid pathway 236 at the second end 234 ofthe piercing member 230 and second fluid pathway 246 at the second end244 of the delivery member 240 are accordingly disposed within the vial25 (not pictured) when device 210 is mated to the vial 25 as describedabove.

Several complete fluid pathways are provided accordingly. Fluid may flowfrom the first end 232 of piercing member 230, through the piercingmember 230, from the second end 234 of piercing member 230 into the vial25, from the vial 25 into the second end 244 of delivery member 240,through the delivery member 240 via the second fluid pathway 246, andfrom the first end 242 of the delivery member 240 to and/or into adelivery site, e.g., an IV line, connected to a patient. Alternatively,fluid may flow from the first end 232 of piercing member 230, throughthe delivery member 240 via the third fluid pathway 248, and from thefirst end 242 of the delivery member 240 to and/or into a delivery site,e.g., an IV line, connected to a patient.

Providing for multiple fluid pathways from the piercing member 230 maybe beneficial, for example, to regulate the dosing of vitamins. Forexample, if a multivitamin composition is administered too quickly, someof the vitamins may, likewise, be excreted too quickly, without havinghad the chance to be fully absorbed by the body. In other words, theremay be circumstances where a delivered bolus may be too concentrated.Accordingly, by providing multiple fluid pathways, some of which do notinteract with the vial 25 (e.g., third fluid pathway 248),reconstitution device 210 may provide a more moderate bolus, thusextending or prolonging the administration of a composition.

As used in this specification, including the claims, the term “and/or”is a conjunction that is either inclusive or exclusive. Accordingly, theterm “and/or” either signifies the presence of two or more things in agroup or signifies that one selection may be made from a group ofalternatives.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the claimed inventions totheir fullest extent. The examples and embodiments disclosed herein areto be construed as merely illustrative and not a limitation of the scopeof the present disclosure in any way. It will be apparent to thosehaving skill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples discussed. In other words, various modifications andimprovements of the embodiments specifically disclosed in thedescription above are within the scope of the appended claims. Forexample, any suitable combination of features of the various embodimentsdescribed is contemplated. Note that elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. § 112 ¶6. The scope of the invention is therefore definedby the following claims.

1.-20. (canceled)
 21. A reconstitution device comprising: a piercingmember having a first end and a second end, the first end of thepiercing member configured to engage an administration port; a deliverymember having a first end and a second end, the first end of thedelivery member configured to engage a delivery site; a collarconfigured to engage a vial; and a cap extending from the collar andholding the piercing member and the delivery member such that the secondend of the piercing member and the second end of the delivery member aredisposed within the collar, wherein the piercing member extends throughthe cap to form a first half and a second half of the piercing member,the first half of the piercing member extends from a top surface of thecap to form the first end of the piercing member and the second half ofthe piercing member extends from a bottom surface of the cap to form thesecond end of the piercing member.
 22. The reconstitution device ofclaim 21, wherein the cap is formed integrally with the collar.
 23. Thereconstitution device of claim 21, wherein the collar is cylindrical andis configured to concentrically engage the vial.
 24. The reconstitutiondevice of claim 21, wherein the collar engages with the vial, such thatthe piercing member is in fluid communication with the vial and thedelivery member is in fluid communication with the vial.
 25. Thereconstitution device of claim 21, wherein the administration port is anintravenous (“IV”) bag port, and wherein the first end of the piercingmember is configured to pierce the IV bag port.
 26. The reconstitutiondevice of claim 21, wherein the delivery site is an IV line, connectableto a patient, and wherein the first end of the delivery member isconfigured to connect to the IV line.
 27. The reconstitution device ofclaim 21, wherein, when placed in an operating position, each of thepiercing member and the delivery member are oriented vertically.
 28. Thereconstitution device of claim 21, wherein the first end of the piercingmember is formed integrally with the administration port.
 29. Thereconstitution device of claim 28, wherein the administration port isconnected to an IV solution container.
 30. The reconstitution device ofclaim 21, wherein at least one of the first end of the piercing member,the second end of the piercing member, and the second end of thedelivery member includes a syringe needle.
 31. A reconstitution systemcomprising: a drug vial; a fluid container; and a reconstitution device,the reconstitution device including: a piercing member having a firstend and a second end, the first end of the piercing member configured toengage the fluid container, a delivery member having a first end and asecond end, the first end of the delivery member configured to engage adelivery site, a collar, and a cap extending from the collar and holdingthe piercing member and the delivery member such that the second end ofthe piercing member and the second end of the delivery member aredisposed within the collar, wherein the piercing member extends throughthe cap to form a first half and a second half of the piercing member,the first half of the piercing member extends from a top surface of thecap to form the first end of the piercing member and the second half ofthe piercing member extends from a bottom surface of the cap to form thesecond end of the piercing member.
 32. The reconstitution system ofclaim 31, wherein the collar engages the vial, such that the piercingmember is in fluid communication with the vial and the delivery memberis in fluid communication with the vial.
 33. The reconstitution systemof claim 32, wherein the fluid container holds a fluid, such that thefluid may travel from the fluid container into the first end of thepiercing member, through the piercing member, from the second end of thepiercing member into the vial, from the vial into the second end of thedelivery member, through the delivery member, and from the first end ofthe delivery member to the delivery site.
 34. The reconstitution systemof claim 31, wherein the vial contains an active agent.
 35. Thereconstitution system of claim 34, wherein the active agent is apharmaceutical agent or a nutritional supplement.
 36. The reconstitutionsystem of claim 31, wherein the fluid container is an IV bag and thedelivery site is an IV line connectable to a patient.
 37. Thereconstitution system of claim 36, further including an infusion pump inoperable communication with the IV line.
 38. The reconstitution systemof claim 31, wherein the fluid container is formed integrally with thereconstitution device.
 39. A method of using a reconstitution systemcomprising: providing a collar that engages a vial and includes a capextending from the collar, the cap holding a piercing member having afirst end and a second end, the piercing member extending through thecap to form a first half and a second half of the piercing member, thefirst half of the piercing member extending from a top surface of thecap to form the first end of the piercing member and a second half ofthe piercing member extending from a bottom surface of the cap to formthe second end of the piercing member; placing the piercing member and adelivery member to be in simultaneous communication with an inside of avial; introducing a fluid from a container, via the first end andthrough the second end of the piercing member, into the vial to mix withan agent located within the vial to form a mixed drug; and deliveringthe mixed drug from the vial together with the fluid from the container,via the delivery member.
 40. The method of claim 39, wherein deliveringthe mixed drug from the vial, via the delivery member, includesconnecting a distal end of the delivery member to a tube that isconnectable to a patient.